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To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Transplant | Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Transplant | Diagnostic Test | Patients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results. |
| Measure | Description | Time Frame |
|---|---|---|
| To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. | The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. | The secondary endpoint for this study is defined as obtaining the results of the RNAseq testing and to ascertain whether an assay for detection of disease recurrence can be developed. | 3 years |
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Inclusion Criteria:
Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
Patients with increased risk of rejection. Patients must meet at least one of the following criteria:
Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
Recipients of donation-after-cardiac death (DCD) donors
Recipients of simultaneous liver-kidney transplantation
Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).
Exclusion Criteria:
Adult ( ≥ = 18 years) renal transplant recipient.
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Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).
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| Name | Affiliation | Role |
|---|---|---|
| Mark Stegall, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Any unused specimens will be destroyed or stored at Mayo Clinic. Peripheral blood obtained under this protocol may be used in future assays to reevaluate biological responses as additional research tests are developed or refined over time. Samples may be used to look at genetic information in relation to liver transplantation (for example, the rejection process). However, samples could also be used in studies that are not related to transplantation (for example, the immune system as a whole).
Specimens will not be stored for longer than 15 years after the closure of the study. Appropriate informed consent will be obtained for both the collection and storage of samples. Any future research identified will be reviewed and approved by an Institutional Review Board.
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |